November 29, 2000 00-48RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT New Attitudes brand Tomato Basil Potato Tubes (snack food), in 14-ounce bags. Recall #F-047-1. CODE All product on the market at time of recall initiation. MANUFACTURER Miss Arachew, Quebec, Canada. RECALLED BY New Attitudes Food Group LLC, Stoughton, Massachusetts, by letter dated October 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 104,000 bags were distributed. REASON Product is mislabeled in that the narrative on the bag states that the product does "not contain any dairy or animal by-products" when in fact the product contains whey powder which is listed as an ingredient on the label. ________ PRODUCT Wing Cheong brand Garlic Flake, packaged in 7-ounce (200 g) plastic bags. Recall #F-049-1. CODE None. All product on the market at time of recall initiation. MANUFACTURER Po Huat (H.K.) Company, Ltd., Hong Kong, China (packer). RECALLED BY Summit Import Corporation, New York, New York (importer), by letter on August 25, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Michigan, Florida. QUANTITY 10 cases (100 7-ounce packages per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Dried Fruit or Preserved Fruit (Plum), in 5.3-ounce (150 gram) rigid plastic tray, in flexible plastic. Recall #F-050-1. CODE None. All product on the market at time of recall initiation. MANUFACTURER Jiangmen Company of Guangdong Foreign Economic Development Corporation, Guangdong, China. RECALLED BY Allied Imports, Inc., Brooklyn, New York (importer), by visit on June 23, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Ohio, Pennsylvania, Virginia. QUANTITY 60 cases (50 5.3-ounce packages per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Rhizoma Dioscoreae Oppsitae (herb), in 12-ounce (340 grams) clear flexible plastic bags. Recall #F-053-1. CODE None. All product on the market at time of recall initiation. MANUFACTURER Jiangmen Company of Guangdong Foreign Economic Development Corporation, Jiangmen, Guangdong, China. RECALLED BY Allied Imports, Inc., Brooklyn, New York, by visit on April 20, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 66 cases (50 12-ounce packages per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Puyallup 1st Fair Oatmeal Raisin Cookie in 13-ounce waxed paper bag. Recall #F-052-1. CODE 11 05. MANUFACTURER Puget Sound Baking Company, Redmond, Washington. RECALLED BY Quality Food Centers, Inc., Bellevue, Washington, by fax on November 1, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 151 packages and 198 individual loose cookies were distributed. REASON Product contained undeclared almonds.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Minute Maid Premium Orange Juice with Calcium, in 64-fluid ounce (1/2 gallon) globe top carton. Recall #F-041-1. CODE SEPT 22 Codes: LE7 1118 or LE7 1119. MANUFACTURER Cutrale Citrus Juices USA, Leesburg, Florida. RECALLED BY The Minute Maid Company, Houston, Texas, by visit on August 25, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 12 affected cases were shipped in 45 case shipment. REASON Some containers may contain dilute acid sanitizer. ________ PRODUCT JFH brand Dried Shrimp, in 1, 2 and 8-ounce retail packages in plastic pouch. Recall #F-048-1. CODE None. All product on the market at time of recall initiation. REPACKER Japan Food Inc., Hawaii, Honolulu, Hawaii. RECALLED BY Repacker, by visit beginning July 25, 2000, followed by fax. Firm-initiated recall ongoing. DISTRIBUTION Hawaii. QUANTITY 3,672 1-ounce; 2,280 2-ounce; and 60 8-ounce packages were distributed. REASON Product contains undeclared sulfites. ________ PRODUCT Oriental Mascot brand Garlic Flake, in 8-ounce (227 g) plastic jars. Recall #F-051-1. CODE None. All product on the market at time of recall initiation. MANUFACTURER Product of China. RECALLED BY Summit Import Corporation, New York, New York (importer), by letter on August 25, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 11 cases (12 8-ounce jars per case) were distributed. REASON Product contained undeclared sulfites.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Touro brand Rx (cough and cold; allergy), in unit dose packages of physician samples as follows: a) TOURO ALLERGY Capsule, (Brompheniramine Maleate 5.75 mg and Pseudoephedrine 60 mg), Physician sample, b) TOURO CC Caplets, (Dextromethorphan hydrobromide 30 mg, Pseudoephrine 60 mg and Guaifensin 575 mg), Physician sample, c) TOURO DM Caplets, (Dextromethorphan hydrobromide 30 mg and Guaifensin 575 mg), Physician sample, d) TOURO EX Caplets, (Guaifensin 575 mg), Physician sample, e) TOURO LA Caplets, (Pseudoephrine HCL 120 mg and Guaifensin 575 mg), Physician sample. Recall #D-031/035-1. CODE LOT Numbers: a) 419; b) 772; c) 471; d) 394C01; e) 699. MANUFACTURER PharmaFab, Grand Prairie, Texas. RECALLED BY Darthmouth Pharmaceuticals, Inc., Wareham, Massachusetts (repacker), by letter beginning on October 18, 2000. Firm- initiated recall ongoing. DISTRIBUTION Connecticut, Massachusetts, Rhode Island. QUANTITY The amount of product in commerce is approximately as follows: Touro Allergy 966 boxes of 30 UDPs; Touro CC 1004 boxes of 30 UDPs; Touro DM 888 boxes of 30 UDPs; Touro EX 546 boxes of 30 UDPs; Touro LA 670 boxes of 30 UDPs. REASON Lack of data to support labeled expiration date. ________ PRODUCT ALLERx(tm) Tablets, Pseudoephedrine HCL 120 mg, Methscopolamine Nitrate 2.5 mg, Chlorpheniramine Maleate 8 mg), 10 day trade pack, Rx. Recall #D-036-1. CODE Lot #0G06701. MANUFACTURER Adams Laboratories, Inc., Fort Worth, exas. RECALLED BY Manufacturer, by telephone beginning October 10, 2000, followed by letter on October 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 7,678 individual units were distributed; firm estimated that less than 5 percent of product remained on market at time of recall initiation. REASON Tablets in reverse order for AM and PM dispensing.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Plasma, Cryo Poor. Recall #B-314-1. CODE Unit Numbers: 12430-3715, 12430-4007, 12430-4010, 12430-4011, 12430-4012, 12430-4013, 12430-4014, 12430-4016, 12430-4017, 12430-4019, 12430-4272, 12430-4277, 12430-4279, 12430-4284, 12430-4285, 12430-4286, 12430-4287, 12430-4289, 12430-4291, 12430-4292, 12430-4293, 12430-4294, 12430-4536, 12430-4540, 12430-4543, 12430-4549, 12430-4552, 12430-4554, 12430-4556, 12430-4565, 12430-5568, 12430-5589, 12430-5612, 12430-5616, 12430-7501, 12430-7503, 12430-7504, 12430-7507. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 28, 1999. Firm-initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 38 units were distributed. REASON Blood products were incorrectly tested for unexpected antibodies. ________ PRODUCT Red Blood Cells, Pheresis. Recall #B-319-1. CODE Unit #LJ60105. MANUFACTURER Mid-South Regional Blood Center, Memphis, Tennessee. RECALLED BY Manufacturer, by letter dated December 15, 1997. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-322-1. CODE Unit #8507209. MANUFACTURER Poudre Valley Health Systems Blood Bank, Fort Collins, Colorado. RECALLED BY Manufacturer, by telephone and fax on January 20, 1999. Firm-initiated recall ongoing. DISTRIBUTION Colorado. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Platelets, Pooled. Recall #B-327-1. CODE Unit #P01467. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on August 11, 2000, and by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had experienced a life- threatening allergic reaction to a medication.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells. Recall #B-315-1. CODE Unit #31125-6025. MANUFACTURER Blood Systems, Inc., Tupelo, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on April 20, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Mobile Digital Imaging Systems, C-Arm fluoroscopic x-rays: a) Series 7700; b) Compact 7700. Recall #Z-005/006-1. CODE None. MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, Utah. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan letter on October 26, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 218 units were distributed. REASON The diagnostic x-ray devices were found defective under 21 CFR 1003.10 and failed to comply with the performance standard in 21 CFR 1020.32(c). The defect occurs as a result of the emission of electronic product radiation that is unnecessary to the accomplishment of its primary purpose and which creates a risk of injury to the operator and patient. The system also failed to meet the fluoroscopic performance standard 21 CFR 1020.32(c) "X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure". ________ PRODUCT Series 9800 Mobile Digital Imaging Systems, C-Arm Fluoroscopic x-rays. Recall #Z-007-1. CODE Series 9800. MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, Utah. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan letter on October 26, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 795 units were distributed. REASON The diagnostic x-ray devices were found defective under 21 CFR 1003.10. The defect occurs as a result of the emission of electronic product radiation that is unnecessary to the accomplishment of its primary purpose and which creates a risk of injury to the operator and patient. ________ PRODUCT Vitros Calibration Diskette DRV 5285, for use with Vitros 250 and 950 Chemistry Systems, when used in conjunction with Generation 48 Digoxin Slides: a) Catalog #825 1878 Vitros 250 Chemistry System; b) Catalog #871 6607 Vitros 950 Chemistry System. Recall #Z-018/019-1. CODE Data Release Version 5825. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by telephone on or about November 13, 1998. Firm-initiated field correction complete. DISTRIBUTION Nationwide, England, France, Germany, Italy. QUANTITY 1,643 diskettes, affecting over 1,902 Digoxin Gen 48 packs. REASON The Vitros Calibration Diskette DRV 5285 contained revised parameters that affected the time during which readings were taken by the instrument to calculate reaction rates. This resulted in a shift in digoxin predicted concentration. For customers who received Digoxin GEN 48 Slides and calibrated using an earlier release of the calibration diskette, loading of DRV 5285 without recalibration of Digoxin GEN 48 slides resulted in a negative shift in digoxin results by approximately 1.5 ng/ml. ________ PRODUCT Steri-Oss brand HL Cylindrical Implants (Endosseous Implants), TPS Coated, 3.25D by14mm, Catalog #3214TPS, device that are surgically placed in the upper or lower jaw to provide support for a prosthetic device, such as artificial teeth and to restore the patients chewing function. Recall #Z-026-1. CODE Lot #993719. MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California. RECALLED BY Manufacturer, by letter dated August 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arizona, California, Connecticut, Georgia, Kentucky, Massachusetts, New York, Oregon, Texas, Israel, Japan. QUANTITY 59 units were distributed. REASON The inner vial label and the vial cap were mislabeled as 12 mm and not 14 mm. ________ PRODUCT META Pulse Generators. Recall #Z-036-1. CODE Model 1256. MANUFACTURER Teletronics Pacing Systems, Miami Lakes, Florida. RECALLED BY St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California, by letter June 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,848 were implanted. REASON These devices have shown an increased risk of failure of the pacer processing integrated circuits (IC) that controls the pulse generator. This failure is most commonly characterized by sensing or output anomalies, including the possibility of no output. Extensive analysis has shown that the IC failure is due to electrostatic discharge (ESD) during manufacturing. ________ PRODUCT GemStar Ambulatory PCA Infusion Pump. Recall #Z-047-1. CODE List #13000. MANUFACTURER Abbott Laboratories, San Diego, California. RECALLED BY Manufacturer, by letter September 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 500 units were distributed. REASON The devices have a dimensional problem in the latch retaining pin for the battery door that can work its way out of the door and then the door cannot be closed. ________ PRODUCT Accu-Chek Voicemate System, Catalog #2030802, designed for testing glucose in whole blood by visually impaired persons with diabetes. Recall #Z-066-1. CODE Lot #119164 and serial number on meter 7674342975. MANUFACTURER SCI Systems, Inc., Huntsville, Alabama. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by telephone on or about October 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 200 units were distributed. REASON The Advantage blood glucose meter placed in one system reports results in mmol/L instead of mg/Dl, which may result in an 18-fold difference in the numbers reported out to the patient over the voice readout of the device. ________ PRODUCT Esprit Ventilator with 10.4-inch Display, color capable. Recall #Z-067-1. CODE Various serial numbers. MANUFACTURER Respironics, Inc., Vista, California. RECALLED BY Manufacturer, by telephone on or about September 21, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and Japan. QUANTITY 53 units were distributed. REASON There is a design deficiency and the backlight inverter PCB needs to be insulated. ________ PRODUCT Belisle brand Advanced Facial Muscular Therapy, an electrical muscle stimulator system. Recall #Z-075-1. CODE All units. MANUFACTURER Belisle Systems, Inc., Clearwater, Florida. RECALLED BY Manufacturer, by letter on July 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION Texas, New York, California, Kansas, Oklahoma, Georgia, Virginia, Oklahoma, Florida, North Dakota, Louisiana. QUANTITY 30 units. REASON Device was marketed without a 510(k) or PMA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT a) Ventrix(r) brand of Ventricular Tunneling Pressure Monitoring Kit, Model NL950-V; b) Complete Ventricular Tunneling Kit, Model #NL950-C. Both products are used to monitor intracranial pressure and drain cerebral spinal fluid. Recall #Z-059/060-1. CODE Lot Numbers: a) 020400; b) VC1040 and VC1041. MANUFACTURER Integra Neurosciences, San Deigo, California. RECALLED BY Manufacturer, by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama, Arkansas, California, Illinois, Massachusetts, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Venezuela. QUANTITY 84 units were distributed. REASON Some kits were packaged with an incorrect trocar/sheath assembly. The kits were supposed to contain 9-10 French size, but were mistakenly packaged with 4-6 French size. ________ PRODUCT Roche Control Serum N (Human), Catalog #0737119, intended as an assayed quality control material to monitor the accuracy and precision at normal concentration levels in quantitative clinical chemistry assays. Recall #Z-061-1. CODE Lot #U0434 EXP 1/31/02. MANUFACTURER Roche Diagnostics Corporation, Indianapolis, Indiana. RECALLED BY Manufacturer, by customer bulletin sent on September 18, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 750 kits with 20 vials each were distributed. REASON The normal control show a significant decrease in recovery of Direct Bilirubin. The Direct Bilirubin recovery shows bottle-to-bottle inconsistencies within the affected lot. ________ PRODUCT Roche Creatinine Enzymatic Reagent, COBAS Integra 400 and 700 Analyzer Operators, Catalog #0763144, reagent intended for use on the COBAS Integra analyzer for the kinetic quantitative determination of creatinine concentration in serum, plasma or urine. Recall #Z-062-1. CODE All lot numbers. MANUFACTURER Roche Diagnostics, Mannheim, Germany. RECALLED BY Roche Diagnostics, Corporation, Indianapolis, Indiana, by letter on September 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,010 units were distributed. REASON Device may give falsely negative results due to hemoglobin interference. The firm’s medical expert determined that this negative interference can be clinically significant, especially in neonates and children because their creatinine levels are lower in general. _______ PRODUCT Elecys Estradiol Assay, Catalog #1776002, an in-vitro quantitative determination of estradiol in human serum and plasma. Recall #Z-063-1. CODE Lot #199871. MANUFACTURER Roche Diagnostics, GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by customer bulletin issued on April 12, 2000, and an urgent product correction notice issued on September 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,636 kits were distributed. REASON A shift in recovery was identified for this lot in comparison to the previous lot manufactured. This shift primarily affects samples from males, post menopausal women and IVF patient. ________ PRODUCT Tina-Quant CRP, for the quantitative measure of C-reactive protein (CRP) in serum and plasma on automated clinical chemistry analyzers: a) Catalog #1551922; b) Catalog #1299859. Recall #Z-064/065-1. CODE All lot numbers. MANUFACTURER Nissui Pharmaceutical Company, Ltd., Tokyo, Japan. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana (distributor), by letter (Customer Bulletin #00-092) dated May 8, 2000. Firm-initiated field correction complete. DISTRIBUTION Nationwide and Canada. QUANTITY 3,042 kits were distributed. REASON Neonatal specimens may initially produce falsely elevated CRP results.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
________ PRODUCT Liquichlor w/Cerumene (chloramphenicol prednisolone-tetracaine suspension) labeled for the topical treatment of otitis exterma and pyoderma in dogs and cats, in 10 ml and 12-ounce tubes. Recall V-006-1. CODE Lot #1755 (EXP 09/00) Lot #1854 (EXP 10/00) Lot #2253 (EXP 04/01) Lot #2434 (EXP 06/01) Lot #2514 (EXP 08/01) Lot #2003 (EXP 12/00) (lot rejected and destroyed 11/11/99) Lot #2074 (EXP 02/01) (lot rejected and destroyed 11/11/99) Lot #1667 (EXP 07/00) Lot #1819 (EXP 10/00) Lot #2499 (EXP 07/01). MANUFACTURER Evsco Pharmaceuticals, Affiliate of IGI, Inc., Buena, New Jersey. RECALLED BY Manufacturer, by letters faxed on May 22, 2000, and July 24, 2000, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Israel. QUANTITY 22,911 dozen and 13,872 tubes were distributed. REASON Product is subpotent.RECALLS AND FIELD CORRECTIONS: VETERINARY RODUCTS -- CLASS III
________ PRODUCT "Snap" Beta-Lactam Test Kit, 20 and 100 Test Kit. Recall #V-005-1. CODE Lot #950ET, contains 20 and 100-count kits as follows: 20-count kits are identified as Lot #09695-950ET; 100-count kits are identified as Lot #09693-950ET. Entire lot has expiration date of 4/19/01. MANUFACTURER IDEXX Laboratories, Inc., Westbrook, Maine. RECALLED BY Manufacturer, by telephone on September 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Brazil, Canada, Costa Rica, Honduras, Taiwan. QUANTITY 5,976 20-kit packs and 677 100-kit packs were distributed. REASON Test kits have identified a high number of false positives.END OF ENFORCEMENT REPORT FOR NOVEMBER 29, 2000. ####
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